Ranking Member Cassidy Raises Concerns over Biden-Harris Admin Delaying Implementation of Bipartisan Law to Improve Lifesaving Organ Donation System

WASHINGTON – U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, raised concerns over the Health Resources and Services Administration’s (HRSA) delays in implementing his Securing the U.S. Organ Procurement and Transplantation Network Act, legislation which streamlines the U.S. organ donation network to allow more Americans access to lifesaving organ transplants.  

Since 1984, the United Network for Organ Sharing (UNOS) has held a monopoly as the sole contractor responsible for managing the Organ Procurement and Transplantation Network (OPTN), despite numerous reports of mismanagement and underperformance. OPTN has historically faced serious challenges including lost or damaged organs, cybersecurity incidents affecting patient information, and antiquated technology infrastructure. Cassidy’s legislation, which Congress passed unanimously last year, sought to address these challenges by breaking up this monopoly and implementing crucial reforms to improve the network’s operations. 

However, HRSA has still failed to enact many of these reforms to improve the management and functions of OPTN. This comes as over 103,000 Americans are still on the national transplant waiting list. 

“Despite this mandate from Congress, HRSA has been slow to implement these much-needed reforms... As the Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, HRSA’s lack of urgency implementing these important reforms is very concerning,” wrote Dr. Cassidy. “As the agency tasked with overseeing the OPTN, the Health Resources and Services Administration (HRSA) must ensure that the OPTN improves its efficiency so that more patients can receive the gift of a lifesaving organ.” 

Read the full letter here or below.  

Dear Administrator Johnson:

In 2023, 46,632 organ transplants were performed, marking the eleventh consecutive year with a record number of transplant procedures.^[1] This was made possible by the generosity of more than 22,000 donors.^[2] Despite this progress, however, over 103,000 men, women, and children are currently on the national transplant waiting list.^[3] The Organ Procurement and Transplantation Network (OPTN) has historically faced numerous challenges, including lost or damaged organs, cybersecurity incidents affecting patient information, and antiquated technology infrastructure.^[4] As the agency tasked with overseeing the OPTN, the Health Resources and Services Administration (HRSA) must ensure that the OPTN improves its efficiency so that more patients can receive the gift of a lifesaving organ.

Last year, Congress passed the Securing the U.S. Organ Procurement and Transplantation Network Act, a bill that I co-sponsored to modernize the OPTN in response to complaints raised against the United Network for Organ Sharing (UNOS), the non-profit entity HRSA contracts with to manage the OPTN.^[5] As part of this legislation, Congress gave HRSA the authority to award multiple contracts to support the operations and functions of the OPTN in order increase competition and make improvements to the OPTN’s management.

Despite this mandate from Congress, HRSA has been slow to implement these much-needed reforms. In fact, it just recently issued final requests for proposals (RFPs) to support multiple contract awards related to board of directors’ support and operations in May and formally incorporated an independent board of directors in June.^[6] Additionally, HRSA has yet to release details about steps to improve the OPTN’s IT infrastructure through the forthcoming Next Gen contract solicitations. These steps to modernize the OPTN are essential to transition to a functioning system given the past challenges the OPTN has faced.^[7] As the Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, HRSA’s lack of urgency implementing these important reforms is very concerning. To that end, I ask that you answer the following questions on a question-by-question basis by September 24, 2024:

1. In June, HRSA announced that it had implemented a new board of directors for the OPTN. When does the OPTN intend to nominate new board members?

2. In July, HRSA announced that it would be holding a special election for new board members later this fall. What informed HRSA’s decision to hold a special election for the new board members?
1. Did HRSA consider an appointments process for the new OPTN board members?

3. What policies and procedures will HRSA implement for the special election of the OPTN board?

4. What steps is the OPTN taking to ensure future both future and current board members do not have any conflicts of interest?

5. How does HRSA intend to fill management positions within the OPTN, including the executive director role? Will HRSA directly appoint OPTN executive and management roles or will future openings be made publicly available?

6. What steps is the OPTN taking to ensure future management positions within OPTN do not have any conflicts of interest?

7. HRSA has stated that it intends to release solicitations for proposals related to its Next Gen Contracts to modernize the OPTN. When does HRSA expect to release those proposals?

8. How regularly does HRSA receive organ procurement data from the OPTN?

1. What information is included as part of those transmissions?
2. How is this data formatted?
3. Does HRSA need specific software or tools to access this data?

9. What ownership or control rights does HRSA assert over organ procurement data collected through the OPTN?

10. Does HRSA have any requirements to delete historical data in its contract with the current OPTN should it not extend that contract?

11. What steps does HRSA have in place to ensure there is no disruption in services if transitioning between information technology (IT) systems?

12. What IT functions has HRSA identified as needing improvement as part of any future technical system?

13. Is HRSA considering the ability of multiple vendors to service OPTN’s IT infrastructure? If so, please explain. If not, why not?

14. HRSA assesses a registration fee on entities who list organ candidates on the OPTN network. How is HRSA monitoring that process and does it anticipate any fee changes as part of its broader modernization efforts?

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